Tenapanor is the newest FDA-approved drug for IBS with constipation (IBS-C). This study seeks to understand tenapanor as a treatment for cystic fibrosis-related constipation (CFrC) in CF patients. Participants will ingest one 50 mg tablet of tenapanor, twice daily, for a 4-week treatment period. They will also complete three questionnaires, the PAC-SYM, PAC-QoL, and IBS-SSS, and daily diaries to characterize GI symptom burden and spontaneous bowel movement (SBM) frequency.

Start Date01 Jun 2025

Sponsor / Collaborator

The Massachusetts General Hospital

[+1]

NCT06460038

/ RecruitingPhase 2IIT

Efficacy and Safety of Tenapanor in Synucleinopathy-Related Constipation

Investigation of tenapanor as a potential treatment for synucleinopathy-associated constipation

Start Date01 Jan 2025

Sponsor / Collaborator

Ardelyx, Inc.

NCT06553547

/ RecruitingPhase 2

4-Week, Multi-Center, Randomized, Db-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Safety & Efficacy of Tenapanor for the T/t of IBS-C in Pts. 6 to < 12 Yrs. Old

This is a randomized, double-blind, placebo-controlled dose-ranging study to assess the safety and efficacy of tenapanor for treatment of the IBS-C in pediatric patients 6 to less than 12 year old.

Start Date24 Jul 2024

Sponsor / Collaborator

Ardelyx, Inc.

100 Clinical Results associated with Tenapanor Hydrochloride

100 Translational Medicine associated with Tenapanor Hydrochloride

100 Patents (Medical) associated with Tenapanor Hydrochloride

126

Literatures (Medical) associated with Tenapanor Hydrochloride

31 Dec 2025·CLINICAL AND EXPERIMENTAL HYPERTENSION

High-salt diets provoke phosphorus absorption from the small intestine in mice

Article

Author: You, Huaizhou ; Yang, Mingxin ; Chen, Jing ; Mao, Jianping ; Ni, Li

BACKGROUND:

Recent studies indicate that tenapanor, an inhibitor of sodium/proton exchanger-3 (NHE3), diminishes intestinal phosphorus (Pi) absorption. Given NHE3's pivotal role in sodium (Na+) metabolism, there is a suspected functional link between Na+ and Pi metabolism. High-salt diets (HSD) have been demonstrated to disrupt calcium (Ca2+) metabolism. Since Ca2+ and Pi share analogous metabolic pathways, it is yet to be determined whether HSD also impacts Pi metabolism.

METHODS:

Male C57 mice were randomly assigned to three groups: a standard diet group, HSD groups for 1 week (HSD-1w) and 4 weeks (HSD-4w). Throughout the study, dietary intake and water consumption were monitored using metabolic cages, and urine and feces were collected. Blood pressure was measured using a noninvasive tail vein sphygmomanometer. Upon completion of the intervention, mice were euthanized under anesthesia for blood collection, and intestinal and renal tissues were harvested for molecular analysis.

RESULTS:

Although plasma Pi levels were comparable between HSD groups and the control group, HSD groups exhibited increased urinary Pi excretion and decreased fecal Pi excretion. The HSD-4w group displayed elevated parathyroid hormone levels, reduced fibroblast growth factor 23 levels, and higher renal Cyp27b1 mRNA expression. The expression of sodium-dependent phosphate transporter 2b (Npt2b) and NHE3 was elevated in the intestine of HSD mice.

CONCLUSION:

HSD disrupts Pi metabolism by enhancing urinary Pi excretion and altering hormonal levels. The decrease in fecal Pi excretion, coupled with the upregulation of intestinal Pi transporter expression, suggests that HSD promotes intestinal Pi absorption in mice.

01 Oct 2025·AMERICAN JOURNAL OF KIDNEY DISEASES

Tenapanor: An Update on Evidence of Effectiveness and Guidance on Practical Use

Review

Author: Uribarri, Jaime ; Da Silva Lugo, Ian

Hyperphosphatemia remains a major challenge in managing patients with kidney failure and is associated with significant morbidity and mortality. Traditional approaches such as dietary phosphate restriction, oral phosphate binders, and dialysis modifications, even if combined, often provide insufficient control of serum phosphate levels. Tenapanor, a novel therapy that targets intestinal phosphate absorption, has shown promise in reducing serum phosphate as monotherapy and in combination with binders, even though gastrointestinal side effects may occur. Here, we review the available information about the clinical use of tenapanor, including its safety profile, and provide some clinical suggestions for its practical use.

01 Aug 2025·Current Opinion in Endocrinology Diabetes and Obesity

An update on investigation and management of renal bone disease

Review

Author: Kowalczyk, Nicholas S. ; Sprague, Stuart M.

Purpose of review:

Renal bone disease has significant detrimental effects on both cardiovascular and bone health. It is important to understand that the pathophysiologic mechanisms are different from traditional causes of bone disease; and thus, the monitoring and treatment of this disease process requires special attention. Although new guidelines are overdue, progress has been made in the treatment of hyperphosphatemia as well as investigational therapies for renal osteodystrophy.

Recent findings:

At a time when the treatment of hyperphosphatemia in chronic kidney disease was once diet and phosphate binders, the novel agent tenapanor, an inhibitor of NHE3, has since been demonstrated to be effective in patients on dialysis as monotherapy or in conjunction with phosphate binders, potentially improving pill burden. Furthermore, the investigational treatment of osteoporosis in chronic kidney disease has expanded since bone mineral density testing has been adopted in practice in these populations.

Summary:

New pathways for phosphate control are continually being investigated, changing practice patterns and quality of life for patients. Further research is needed in the safety and efficacy of antiresorptive and stimulatory bone agents to target the variety of mechanisms of osteoporosis; however, small studies appear promising and could change the way these patient populations are treated.

173

News (Medical) associated with Tenapanor Hydrochloride

06 Nov 2025

·www.prnewswire.com

Fosun Marks Eighth Year at CIIE, Guo Guangchang Calls for More Cutting-Edge Innovation

HONG KONG, Nov. 6, 2025 /PRNewswire/ -- On 5 November 2025, the 8th China International Import Expo (CIIE) opened at the National Exhibition and Convention Center (Shanghai). As a "full-attendance" exhibitor for eight consecutive years, Fosun, together with its overseas member companies and global partners, is showcasing a range of world-leading innovative drugs, advanced medical devices, and achievements in international collaboration at the Fosun Pharma booth in the Medical Equipment and Healthcare Products Exhibition Area. The exhibits focus on core therapeutic areas including oncology, immune-inflammatory disorders, central nervous system, and kidney diseases, highlighting holistic breakthroughs in medical technology, from diagnosis and treatment to recovery. Guo Guangchang, Chairman of Fosun International, remarked, "Over the past eight years, the CIIE has continued to grow in influence and innovate, serving as a key window into China's new development paradigm, a platform for advancing high-level opening-up, and a global public good that benefits the international community. We have witnessed and benefited from this 'everlasting' showcase. The CIIE has enabled Fosun's global innovations to continuously transform from 'exhibits' into 'products', while many overseas partners have changed their roles from 'exhibitors' to 'investors'. Fosun believes that healthcare innovation should address unmet clinical needs and bring hope of cure to patients. This year, our showcases in the Medical Equipment and Healthcare Products Exhibition Area center on the latest advancements addressing global clinical needs, with several new products making their debut. We firmly believe that China's high-level opening-up will remain a source of certainty and opportunity for global development. Looking ahead, Fosun will further capitalize on its global industrial advantages to foster more cutting-edge innovations in China, contributing the 'power of Fosun' to fulfill people's aspirations for a better life." Focusing on oncology: advancing from "treatment" to "cure" Fosun is presenting a series of cutting-edge innovative products aimed at advancing oncology from "treatment" to "cure" at this year's CIIE. Among them, the debut product, the Marie Upright Particle Therapy System, has attracted significant attention. As a revolutionary breakthrough in cancer treatment, the Marie Upright Particle Therapy System eliminates the cumbersome structure of conventional particle therapy system, enabling rapid deployment within existing medical facilities. Studies show that the upright positioning enhances precision in tumors located in the lung, breast, abdomen, and other areas. The system supports multiple advanced particle therapy modalities including proton therapy, heavy ion therapy, boron neutron capture therapy (BNCT), and FLASH radiotherapy, offering patients more precise, comfortable, and flexible treatment options. The Marie Upright Particle Therapy System, which received U.S. Food and Drug Administration (FDA) approval in July 2025, is making its debut in China at this year's CIIE. In the field of hematologic oncology, Fosun's Yi Kai Da (ejilunsai injection), China's first CAR-T cell therapy product, continues to share the latest developments in making lymphoma treatment both accessible and curative at the CIIE. This year, Yi Kai Da has made multiple major advances: inclusion in over 110 urban customized commercial health insurances and over 80 commercial insurances; establishment of over 190 high-standard treatment centers across 29 provinces and cities nationwide, benefiting more than 1,000 lymphoma patients; successful first-ever cross-border shipping and usage in Hong Kong SAR and Macau SAR; and a remarkable case of the first patient treated with Yi Kai Da in the Chinese mainland achieving over seven years of high-quality survival. Notably, following Yi Kai Da, the drug registration application of Fosun's second CAR-T product, brexucabtagene autoleucel injection, was accepted by the National Medical Products Administration (NMPA) in September 2025. The declared indication for this application is for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Regarding supportive care in cancer, Fosun is showcasing several innovative drugs that fill treatment gaps in the domestic market. These include the world's first and currently only dual-channel antiemetic, Akynzeo (netupitant and palonosetron hydrochloride capsules); China's first oral thrombopoietin receptor agonist with dual indications for chronic liver disease-associated thrombocytopenia and immune thrombocytopenia, Su Ke Xin (avatrombopag maleate tablets); and the long-acting recombinant human granulocyte colony-stimulating factor, Pei Jin (telpegfilgrastim injection). Additionally, Wan Ti Le (tenapanor hydrochloride tablets), a "CIIE baby" introduced to China through the CIIE, received approval from the NMPA in February 2025. It is indicated for the control of serum phosphorus levels in dialysis patients with chronic kidney disease. This groundbreaking innovation has also been shortlisted as a candidate for Best Pharmaceutical Product at the Prix Galien 2025. Addressing neurological disorders with innovative drugs and devices In recent years, the number of patients with neurological disorders has rapidly increased, with a notable trend toward younger patients. Disorders such as Parkinson's disease, brain tumors, and epilepsy have attracted growing attention. Focusing on unmet clinical needs, Fosun is actively exploring world-leading innovative solutions. In advanced medical devices, Fosun is once again featuring cutting-edge non-invasive treatments, the magnetic resonance image guided focused ultrasound brain therapy system (MRgFUS brain therapy system) and the world's first 128-channel helium-free Marvel magnetoencephalography (MEG), at the CIIE, providing integrated solutions from precise localization to non-invasive treatment for common neurological disorders such as Parkinson's disease, brain tumors, and epilepsy. To date, more than 25,000 patients worldwide have benefited from the MRgFUS brain therapy system. Its new V2 model, featuring enhanced device compatibility and easier operation, has obtained CE marking in the European Union and U.S. FDA approval. Since its debut at the last CIIE, the MRgFUS brain therapy system has been deployed in over 10 medical institutions in the Chinese mainland, benefiting nearly 1,000 patients. In the field of innovative drugs, Fosun has introduced a world-leading combination therapy for Parkinson's disease, contributing to the continuous improvement of diagnosis and treatment in China. The oral COMT inhibitor, Ongentys (opicapone) is currently the only once-daily COMT inhibitor approved globally, offering convenient dosing that significantly enhances treatment adherence and long-term disease management. Ongentys is already in clinical use in pilot zones such as Boao Lecheng, leveraging special access policies for clinical prescriptions and paving the way for broader national adoption. Integrating global resources to drive local innovation, embracing AI to accelerate breakthroughs Fosun continues to integrate global resources to advance cutting-edge medical technologies in China. Leveraging CIIE's support in transforming "exhibits" into "products", Intuitive Fosun's surgical system has been gradually launched, contributing to the development of a high-quality healthcare system in China. The Da Vinci surgical system, a popular exhibit at the CIIE for eight consecutive years, has witnessed the rapid development of minimally invasive surgery in China. By the end of September 2025, over 480 Da Vinci surgical systems had been installed in more than 370 hospitals across the Chinese mainland, Hong Kong SAR, and Macau SAR, collectively serving over 810,000 patients. This year, Intuitive Fosun is showcasing several surgical systems, including the domestically produced multiport Da Vinci Xi surgical system, the single-port Da Vinci SP surgical system designed for single-incision or natural orifice surgeries, and the Ion Robotic Bronchoscopy that brings breakthrough innovations in lung cancer diagnosis and treatment. To better meet China's clinical needs, Intuitive Fosun Innovation Center has partnered with over 20 grade 3A hospitals accredited by the National Health Commission of the People's Republic of China to establish Da Vinci Surgical System Training Centers, creating an integrated training system that combines clinical practice with education. To date, Intuitive Fosun has established 7 regional training centers across China and trained more than 15,000 medical professionals, promoting the standardized and sustainable development of surgical systems nationwide. In digital transformation, Fosun actively embraces AI and has gradually built a comprehensive digital and intelligent system covering research and development, operations, and product applications. At this year's CIIE, Fosun Pharma is showcasing its PharmAID decision intelligence platform, which deeply integrates leading large model technologies such as DeepSeek, achieving intelligent leaps in drug commercial decision-making, clinical trial prediction, and toxicology optimization. In medical aesthetics, Sisram is presenting revolutionary solutions including Alma IQ, an intelligent skin analysis and consultation solution, and Universkin, the world's first AI-assisted medical-grade skincare line launched in North America, setting new standards for personalized treatment. In healthcare services, Fosun Health continues to explore deep AI applications in assisted diagnosis, treatment quality control, and proactive health management. Leveraging four core hospitals in the Greater Bay Area including Foshan Fosun Chancheng Hospital, Fosun Health has established an internationalized service platform integrating online and offline resources, providing one-stop services from remote consultation to full patient care for individuals from Japan, Bangladesh, Indonesia, Peru, and other countries. Guo Guangchang said, "Looking ahead, Fosun will leverage its long-established innovation and globalization capabilities, collaborating with global partners to continuously drive high-quality development of the pharmaceutical industry and help realize the ambitious vision of 'Healthy China 2030'." SOURCE Fosun 21% more press release views with Request a Demo

Drug Approval

30 Oct 2025

·www.globenewswire.com

Ardelyx Presents Data that Continues to Support the Benefits of IBSRELA® (tenapanor) at the American College of Gastroenterology’s 2025 Annual Meeting

IBSRELA patients reported treatment satisfaction in real-world survey Post-hoc analysis of T3MPO-1 and T3MPO-2 studies demonstrates effectiveness of IBSRELA in reducing abdominal bloating for patients with IBS-C Analysis of electronic health records suggests IBSRELA may reduce burden to healthcare system Oct. 28, 2025 -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced that the company presented data supporting the company’s first-in-class retainagogue, IBSRELA® (tenapanor) at the American College of Gastroenterology’s (ACG) Annual Scientific Meeting, now underway in Phoenix. IBSRELA is approved by the U.S. Food and Drug Administration to treat irritable bowel syndrome with constipation (IBS-C) in adults. “At Ardelyx, we remain deeply committed to advancing our understanding of the impact IBS-C has on patients and the potential for IBSRELA to address the symptoms of the condition and support an improved quality of life for patients,” said Edward Conner, MD, Chief Medical Officer. “The data we presented at ACG highlights three important aspects of IBS-C that affect patients: That there are gaps in treatment satisfaction, that abdominal bloating is one of the most bothersome symptoms, and that frequent visits to healthcare professionals can be burdensome. Results from these data build on the established efficacy, safety and tolerability profile of IBSRELA and highlight the continued value in helping patients manage the burden of IBS-C.” Poster # P5062, entitled “Treatment Satisfaction With Tenapanor (IBSRELA): Real-World Survey of Patients With Irritable Bowel Syndrome With Constipation,” reports data from a real-world survey of patients receiving tenapanor for the treatment of IBS-C. The survey was conducted to assess treatment satisfaction, IBS-C symptom resolution and improvement in quality of life. Overall, the findings support the effectiveness of tenapanor in the management of IBS-C, with a majority of patients reporting treatment satisfaction (88%) and improvements in constipation (95%), bloating (75%), and abdominal pain (84%). More than 70% of patients reported improved ability to participate in daily activities including work, social activities and exercise. Overall, 76% of participants expressed that tenapanor is better than other IBS-C medications they have used. Poster # P0809, entitled “Tenapanor Improves Abdominal Bloating Symptoms in Patients With IBS-C Experiencing Moderate to Severe Bloating,” demonstrates, based on the Phase 3 T3MPO-1 and T3MPO-2 studies, that tenapanor may be effective in reducing bloating for patients with IBS-C and that a clinically meaningful reduction in bloating can be experienced as early as week one of treatment onset and sustained through the duration of treatment. Abdominal bloating is one of the most bothersome symptoms of IBS-C, yet it is not a typical primary endpoint in clinical trials. Poster # P0787, entitled “Reduction in Gastrointestinal Visits and Portal Messaging Following Tenapanor (IBSRELA) Initiation for Community Gastrointestinal Patients,” reports data from an ongoing electronic health record study to understand real-world use and outcomes of IBS-C medications in community gastrointestinal (GI) practices. The preliminary findings indicate that GI-related clinical encounters and patient portal message activity substantially decreased after tenapanor initiation among patients with high pre-tenapanor healthcare resource utilization (HCRU). This suggests that tenapanor may reduce burden on the healthcare system and patients with IBS-C by reducing high HCRU, potentially leading to cost savings. IBSRELA (tenapanor) is a locally acting inhibitor of the sodium/hydrogen exchanger 3 (NHE3), an antiporter expressed on the apical surface of the small intestine and colon primarily responsible for the absorption of dietary sodium. By inhibiting NHE3 on the apical surface of the enterocytes, tenapanor reduces absorption of sodium from the small intestine and colon, thus retaining luminal water content, which accelerates intestinal transit time and results in a softer stool consistency. IBSRELA has also been shown to reduce abdominal pain by decreasing visceral hypersensitivity and by decreasing intestinal permeability in animal models. In a rat model of colonic hypersensitivity, tenapanor reduced visceral hyperalgesia and normalized colonic sensory neuronal excitability. Irritable bowel syndrome with constipation (IBS-C) is a gastrointestinal disorder characterized by both abdominal pain and altered bowel movements, estimated to affect 12 million people in the U.S. IBS-C is associated with significantly impaired quality of life, reduced productivity, and substantial economic burden. Ardelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA® (tenapanor) and XPHOZAH® (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL® (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada. The content above comes from the network. if any infringement, please contact us to modify.

Clinical ResultDrug ApprovalLicense out/in

21 Oct 2025

·www.globenewswire.com

Ardelyx Announces Four Abstracts Accepted for Poster Presentations at the American Society of Nephrology’s Kidney Week

WALTHAM, Mass., Oct. 21, 2025 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced upcoming data presentations supporting XPHOZAH® (tenapanor) at the American Society of Nephrology’s Kidney Week, to be held November 5-9, 2025, in Houston. XPHOZAH, the first and only phosphate absorption inhibitor (PAI), is approved by the U.S. Food and Drug Administration to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy. XPHOZAH offers a different mechanism of action that blocks phosphate absorption at the primary pathway and is administered as a single tablet taken twice daily. Information regarding ASN's Kidney Week, including copies of presentation abstracts, can be found here. Ardelyx Poster Presentations: Title: Real-World Effectiveness of Tenapanor (XPHOZAH) for Treatment of Hyperphosphatemia in United States Patients on DialysisAuthors: Alan J. Fossa, Dhajanae Sylvertooth, Angelo Karaboyas, Brian Bieber, Roberto Pecoits-Filho, David Rosenbaum, Laura Williams, Luisa ScottPoster Number: TH-PO0221 Date/Time: November 6, 2025, from 10:00 AM – 12:00 PM CST Title: Treatment Satisfaction with Tenapanor (XPHOZAH): Real-World Survey of Patients with End-Stage Renal Disease and HyperphosphatemiaAuthors: Jessica Kendrick, Luisa Scott, Belinda Gist, Laura WilliamsPoster Number: TH-PO0224 Date/Time: November 6, 2025, from 10:00 AM – 12:00 PM CST Title: Tenapanor Improves Bowel Movements in Patients with End-Stage Kidney Disease and Mild to Severe ConstipationAuthors: Steven Fishbane, Suling Zhao, Yang Yang, Susan Edelstein, David M. SpiegelPoster Number: TH-PO0223 Date/Time: November 6, 2025, from 10:00 AM – 12:00 PM CST Title: Etelcalcetide Utilization Rates Decreased and Parathyroidectomy Rates Increased Following the Incorporation of Calcimimetics into the End-Stage Kidney Disease BundleAuthors: Brian Bieber, Angelo Karaboyas, Roberto Pecoits-Filho, Kevin Martin, Stuart SpraguePoster Number: FR-PO0254 Date/Time: November 7, 2025, from 10:00 AM – 12:00 PM CST In addition to the poster presentations during ASN’s Kidney Week, Ardelyx is sponsoring an Exhibitor Spotlight: “Expanding Perspectives in Hyperphosphatemia Treatment; A Different Approach” on November 7, 2025, from 11:00 – 11:45 AM CST, where José A Morfin, MD, FASN, will discuss the first and only phosphate absorption inhibitor with a different non-binder mechanism. Participants can learn about its clinical data, safety, practical considerations, patient cases, and more. About XPHOZAH® (tenapanor)XPHOZAH, discovered and developed by Ardelyx, is a first-in-class, phosphate absorption inhibitor with a differentiated mechanism of action that acts locally in the gut to inhibit the sodium hydrogen exchanger 3 (NHE3), thereby reducing phosphate absorption through the paracellular pathway, the primary pathway of phosphate absorption. XPHOZAH is a single tablet, taken twice daily. Diarrhea was the most common side effect experienced by patients taking XPHOZAH in clinical trials. Please see additional full Prescribing Information. About HyperphosphatemiaHyperphosphatemia is a serious condition, defined as elevated levels of phosphate in the blood, which affects the vast majority of the 550,000 patients in the United States with chronic kidney disease (CKD) on maintenance dialysis. The kidneys are responsible for eliminating excess phosphate and as kidney function declines, phosphate is not adequately eliminated from the body. As a result, hyperphosphatemia is a nearly universal condition among people with CKD on maintenance dialysis, with internationally recognized KDIGO treatment guidelines that recommend lowering elevated phosphate levels toward the normal range (2.5-4.5mg/dL). IMPORTANT SAFETY INFORMATION CONTRAINDICATIONSXPHOZAH is contraindicated in: Pediatric patients under 6 years of agePatients with known or suspected mechanical gastrointestinal obstruction WARNINGS AND PRECAUTIONSDiarrhea Patients may experience severe diarrhea. Treatment with XPHOZAH should be discontinued in patients who develop severe diarrhea. MOST COMMON ADVERSE REACTIONS Diarrhea, which occurred in 43-53% of patients, was the only adverse reaction reported in at least 5% of XPHOZAH-treated patients with CKD on dialysis across trials. The majority of diarrhea events in the XPHOZAH-treated patients were reported to be mild-to-moderate in severity and resolved over time, or with dose reduction. Diarrhea was typically reported soon after initiation but could occur at any time during treatment with XPHOZAH. Severe diarrhea was reported in 5% of XPHOZAH-treated patients in these trials. INDICATION XPHOZAH (tenapanor), 30 mg BID, is indicated to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy. For additional safety information, please see full Prescribing Information. About ArdelyxArdelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA® (tenapanor) and XPHOZAH® (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL® (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada. For more information, please visit https://ardelyx.com/ and connect with us on X (formerly known as Twitter), LinkedIn and Facebook. Investor and Media Contacts: Lindsey Manuellmanuel@ardelyx.com

Drug ApprovalClinical StudyClinical Result

100 Deals associated with Tenapanor Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D11653	Tenapanor Hydrochloride	A06AX	DB11761

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Hyperphosphatemia	Japan	Kyowa Kirin Co., Ltd.	25 Sep 2023
Irritable bowel syndrome with constipation	United States	Ardelyx, Inc.	12 Sep 2019

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Constipation	Phase 3	United States	Ardelyx, Inc.	01 Jun 2025
Kidney Failure, Chronic	Phase 3	United States	Ardelyx, Inc.	01 Jan 2016
Albuminuria	Phase 2	United States	Ardelyx, Inc.	01 May 2013
Albuminuria	Phase 2	United States	AstraZeneca PLC	01 May 2013

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASN2025	Not Applicable	Hyperphosphatemia	13	Tenapanor	zkrckzbydm(endqfndadb) = Diarrhea or loose stools occurred in 7 patients, and 4 required dose reductions. yaojxxgvuq (ulusivsejv )	Negative	06 Nov 2025
NCT02675998 (BLOCK, ASN2025)	Phase 3	Kidney Failure, Chronic \| Constipation	84	Tenapanor 3 mg	dzgbzevyts(rqrsslzchq) = dlmxgyyvoz qqbswzyqei (dtiqwybduz ) View more	Positive	06 Nov 2025
				Tenapanor 10 mg	nbwpqovsxz(ghcuiaeonc) = grgeriisrz demzgxkmwd (uqlyzvmubx ) View more
NCT03824587 (AMPLIFY, ASN2024)	Phase 2/3	Chronic Kidney Diseases	308	Tenapanor + Sevelamer-based PB	fhtsqvmzcy(qbygzfutdj) = hliztufyiz qqwskrwyee (nbvyqxhdqf ) View more	Positive	24 Oct 2024
				Tenapanor + Non-Sevelamer based PB	fhtsqvmzcy(qbygzfutdj) = hywjgbdmdy qqwskrwyee (nbvyqxhdqf ) View more
NCT04549597 (OPTIMIZE, Pubmed \| Kidney360) Manual	Phase 4	Hyperphosphatemia Maintenance	333	Tenapanor in combintenapanorh phosphate binders	owotrhufbc(qxjtoercmm) = hjhaqyaegj kvfronjltf (cqkjefvnjz ) View more	Positive	07 Feb 2024
				reduce PB dosage by ≥50% and add tenapanor (Binder Reduction)	owotrhufbc(qxjtoercmm) = mtudnrpomy kvfronjltf (cqkjefvnjz ) View more
ASN2023	Phase 3	Hyperphosphatemia	212	Tenapanor 5 mg BID	ikvgzucfbp(qflwkkvrow) = flapuztrtn ibnhkazpui (zrzywdesdk ) View more	Positive	02 Nov 2023
ASN2023	Phase 3	Hyperphosphatemia	54	Tenapanor	itzbmxtlet(qmauhbajnh) = diarrhea (74.1%, 40/54). All were mild or moderate in severity and only three subjects (5.6%) discontinued due to diarrhea admlelglpr (tfukewcsrw )	Positive	02 Nov 2023
NCT03427125 (PHREEDOM, ASN2023)	Phase 3	Hyperphosphatemia	556	Tenapanor 30 mg bid	bhvewuckwm(rpthkmqtsg) = fpxruigafh mitliesmmw (yrkmeypmgi ) View more	Positive	02 Nov 2023
				Sevelamer Carbonate	bhvewuckwm(rpthkmqtsg) = gdtcrbxtwb mitliesmmw (yrkmeypmgi ) View more
NCT02621892 \| NCT02727751 \| NCT02686138 (T3MPO-3, Pubmed \| Neurogastroenterol Motil)	Phase 3	Irritable bowel syndrome with constipation	312	Tenapanor 50 mg	spvskuvmsj(qkoffsjnqt) = pvfpxxbumn auikcbwrby (eiawnojxfh ) View more	Positive	01 Nov 2023
NCT03988920 (NORMALIZE, Pubmed \| Kidney360)	Phase 3	Hyperphosphatemia Maintenance serum intact fibroblast growth factor-23 \| serum intact parathyroid hormone	172	Tenapanor 30 mg twice daily	bcjsxpbjgy(juopssawms) = The most commonly reported treatment-emergent adverse event was diarrhea in 38 of 172 patients (22%), which led to tenapanor discontinuation in four patients (2%) sjtggwlviq (xekjvsltra )	Positive	01 Nov 2023
NCT02675998 \| NCT03427125 \| NCT03824587 (TEN-02-202 , FDA) Manual	Phase 2/3	Hyperphosphatemia	964	XPHOZAH (TEN-02-301)	jqqiqrujvy(pomgsczaoz) = kcjukwkmrf rytpyjfuxx (yhlycvapgx, 0.2 - 1.1)	Positive	17 Oct 2023
				placebo (TEN-02-301)	-

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